Understanding ISO 13485:2016

In this two-day training participants will learn the concepts of ISO 13485:2016 as well as gain a clause-by-clause understanding of the standard. This course is designed to provide you with insight into the use of ISO 13485:2016 as the basis for a quality management system implemented by medical device manufacturers, highlighting the value that implementation can bring your overall business management system.

Course Details

Length

2 Days


Prerequisites

None


Learning Objectives

  • Demonstrate an understanding of the purpose and intent of the ISO 13485 standard
  • Define terminology and exclusion requirements in ISO 13485
  • Compare the requirements between ISO 13485 and ISO 9001
  • Interpret the clauses of ISO 13485
  • Recognize the role and responsibilities of management in ISO 13485
  • Appreciate the use of ISO 13485 as the basis of Medical Device Regulations worldwide
  • Recognize the relationship between ISO 13485 and ISO 14971

Who Should Attend

Senior Management, Quality Managers, Regulatory Affairs Managers, Internal and External Auditors, and anyone involved with the implementation of the standard.

Agenda

Day 1

  • Purpose and Objectives
  • Process Approach and Impacts
  • Clause by clause review of ISO 13485

Day 2

  • Clause by clause review of ISO 13485 (continued)
  • Quality Management Principles
  • Closure and Planning: Opportunities, roadblocks and implementation planning